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510(k) K802988

JOTA TUNGSTEN CARBIDE & STEEL DENT. BURS by Swiss American Metal Craft Corp. — Product Code EJL

K802988 is an FDA 510(k) premarket notification submitted by Swiss American Metal Craft Corp. for the device "JOTA TUNGSTEN CARBIDE & STEEL DENT. BURS". The FDA issued a decision of Substantially Equivalent on December 30, 1980. The device falls under product code EJL (Bur, Dental), a Class I device regulated under 21 CFR 872.3240. Swiss American Metal Craft Corp. has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 30, 1980
Date Received
November 21, 1980
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Bur, Dental
Device Class
Class I
Regulation Number
872.3240
Review Panel
DE
Submission Type

Other clearances by Swiss American Metal Craft Corp.

  • K802987 — JOTA DIAMOND DENTAL BURS (December 30, 1980)
  • K802984 — MEISINGER DIAMOND DENTAL BURS (December 30, 1980)
  • K802989 — MEISINGER TUNGSTEN CARBIDE & STEEL DT.B. (December 30, 1980)

Other clearances for product code EJL

  • K080687 — SMARTBURS (June 20, 2008)
  • K071352 — CERADRILL (June 29, 2007)
  • K061383 — BTI STERILE DENTAL DRILLS KIT, BTI ABUTMENTS AND CAPS (August 3, 2006)
  • K943273 — TRI HAWK BUR, FG BUR (August 1, 1994)
  • K926205 — MONOSTERYL (February 10, 1994)
  • K923883 — DENTAL OR SURGICAL BUR (July 27, 1993)
  • K921406 — SILICONT BUR BLOCK (April 28, 1992)
  • K920243 — SMART BURS TOTAL CARBIDES (March 25, 1992)
  • K911208 — TIN COATED DENTAL BURS (September 16, 1991)
  • K910794 — SMALL INSTRUMENT STERILIZATION/BUR BOX (May 23, 1991)

FDA data resources